RFA-OH-22-004 NIH Guide.pdf

RFA-OH-22-004: World Trade Center Health Research-Related to WTC Survivors (U01 no Applications with Responders Accepted) https://grants.nih.gov/grants/guide/rfa-files/RFA-OH-22-004.html[9/7/2021 5:19:40 PM]

Department of Health and Human Services

Part 1. Overview Information Participating Organization(s)

Centers for Disease Control and Prevention (CDC)

The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and

Prevention (CDC) stated in this funding opportunity announcement (FOA) might differ from those used by the HHS National Institutes of Health (NIH). If written guidance for completing this application is not available on the CDC website, then CDC will direct applicants elsewhere for that information.

Components of Participating Organizations

National Institute for Occupational Safety and Health (NIOSH)

Funding Opportunity Title

World Trade Center Health Research related to WTC Survivors

(U01-No Applications with Responders Accepted)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-OH-22-004

Companion Funding Opportunity

None

Number of Applications

RFA-OH-22-004: World Trade Center Health Research-Related to WTC Survivors (U01 no Applications with Responders Accepted)

Key Dates

Eligible applicant institutions may submit more than one application, provided that each application is scientifically distinct. See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.262

Funding Opportunity Purpose

To help address the Zadroga Act research mandate (Public Law 111–347, as amended by

Public Laws 114–113 and 116–59), as supported by the World Trade Center (WTC) Health

Program in consultation with the WTC Health Program Scientific/Technical Advisory

Committee, NIOSH is soliciting applications for scientifically rigorous research (42 U.S.C.

§300mm–51) among enrolled certified-eligible WTC survivors and similarly exposed populations in New York City in Manhattan between Houston Street and 14th Street and in

Brooklyn to help answer critical questions about:

Physical and mental health conditions that may be related to the September 11, 2001, terrorist attacks;

Diagnosing WTC-related health conditions for which there has been diagnostic uncertainty; and

Treating WTC-related health conditions for which there has been treatment uncertainty.

A major area of research interest of this announcement also includes improving the healthcare and wellbeing of at-risk survivor populations including minority groups, women exposed while pregnant or of reproductive age, the elderly, adolescents, and other minor children.

Certified-eligible WTC survivors (adults and children) include individuals who lived, worked, went to school, or attended child or adult day care in the New York City (NYC) Disaster Area, as defined in 42 CFR 88.1, on September 11, 2001, or in the following days, weeks, or months and those otherwise meeting the eligibility criteria in 42 CFR 88.7 or 88.8 who have been identified as eligible for medical monitoring and treatment as described in 42 CFR 88.1 or

88.12(b).

In addition to certified-eligible WTC survivors, proposed research can include sampled populations outside the NYC disaster area in Manhattan as far north as 14th Street and in

Brooklyn, along with control populations, to identify potential for long-term adverse health effects in less exposed populations.

Posted Date

September 03, 2021

Open Date (Earliest Submission Date)

RFA-OH-22-004: World Trade Center Health Research-Related to WTC Survivors (U01 no Applications with Responders Accepted)

November 1, 2021

Letter of Intent Due Date(s)

November 1, 2021; November 1, 2022; November 1, 2023; November 1, 2024

Application Due Date(s)

December 7, 2021; December 6, 2022; December 5, 2023; December 10, 2024

On-time submission requires that electronic applications be error-free and made available to

CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM

Eastern Time on the listed application due date.

Applicant organizations are strongly encouraged to start the registration process at least 4 weeks prior to the application due date.

Note: HHS/CDC grant submission procedures do not provide a period of time beyond the application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March 2022; March 2023; March 2024; March 2025

Advisory Council Review

March 2022; March 2023; March 2024; March 2025

Earliest Start Date

July 1, 2022; July 1, 2023; July 1, 2024; July 1, 2025

Expiration Date

December 13, 2024

Due Dates for E.O. 12372

Not Applicable

RFA-OH-22-004: World Trade Center Health Research-Related to WTC Survivors (U01 no Applications with Responders Accepted)

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application

Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in

Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.

2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Table of Contents Part 1. Overview Information

Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description

Section II. Award Information

Section III. Eligibility Information

Section IV. Application and Submission Information

Section V. Application Review Information

Section VI. Award Administration Information

Section VII. Agency Contacts

Section VIII. Other Information

Part 2. Full Text of Announcement Section I. Funding Opportunity Description

Statutory Authority The World Trade Center (WTC) Health Program is authorized under the James Zadroga

RFA-OH-22-004: World Trade Center Health Research-Related to WTC Survivors (U01 no Applications with Responders Accepted)

9/11 Health and Compensation Act of 2010 (Public Law 111–347, as amended by Public

Laws 114–113 and 116–59); codified in Title XXXIII of the Public Health Service Act at 42

U.S.C. §§ 300mm – 300mm–61, 124 Stat. 3623).

Background The World Trade Center (WTC) Health Program is administered by the National Institute for Occupational Safety and Health (NIOSH). Information on this program is available at the NIOSH WTC Health Program website. The James Zadroga 9/11 Health and

Compensation Act of 2010, Public Law 111–347 (hereafter referred to as “the Zadroga

Act”) was signed by President Obama on January 2, 2011, and was re-authorized on

December 18, 2015 (the Consolidated Appropriations Act, 2016, Public Law 114–113), and further amended by Public Law 116–59. The Zadroga Act established monitoring and treatment activities for responders and survivors of the September 11, 2001, terrorist attacks and requires the establishment (under Subtitle C) of a research program on health conditions resulting from the attacks.

The Zadroga Act lists the following broad research areas (42 U.S.C. §300mm–51):

Physical and mental health conditions that may be related to the September 11, 2001, terrorist attacks;

Diagnosing WTC-related health conditions for which there has been diagnostic uncertainty; and

Treating WTC-related health conditions for which there has been treatment uncertainty.

Research to be conducted under the Zadroga Act includes epidemiologic and other research studies on WTC-related health conditions or emerging conditions among (1) enrolled WTC responders and certified-eligible WTC survivors under treatment; (2) sampled populations outside the NYC disaster area, in Manhattan (as far north as 14th

Street) and in Brooklyn; and (3) control populations, to identify potential for long-term adverse health effects in less exposed populations.

The Zadroga Act specifies establishing a WTC Health Program Scientific/Technical

Advisory Committee and indicates that the WTC Program Administrator shall consult with the committee in carrying out research activities related to the September 11, 2001, terrorist attacks.

Purpose To address the Zadroga Act research mandate as supported by the WTC Health Program and in consultation with the WTC Health Program Scientific/Technical Advisory

Committee, NIOSH is soliciting applications for scientifically rigorous research among enrolled certified-eligible WTC survivors and similarly exposed populations in New York

City in Manhattan between Houston Street and 14th Street and in Brooklyn to both address critical questions about physical and mental health conditions and provide practical treatment and diagnostic benefits for enrollees.

Certified-eligible WTC survivors (adults and children) include individuals who lived, RFA-OH-22-004: World Trade Center Health Research-Related to WTC Survivors (U01 no Applications with Responders Accepted) worked, went to school, or attended child or adult day care in the New York City (NYC)

Disaster Area, as defined in 42 CFR 88.1, on September 11, 2001, or in the following days, weeks, or months and those otherwise meeting the eligibility criteria in 42 CFR 88.7 or 88.8 who have been identified as eligible for medical monitoring and treatment as described in 42 CFR 88.1 or 88.12(b).

In addition to certified-eligible WTC survivors, proposed research can include sampled populations outside the NYC disaster area in Manhattan as far north as 14th Street and in

Brooklyn, along with control populations, to identify potential for long-term adverse health effects in less exposed populations.

Major areas of WTC Survivor research interest include, but are not limited to, the following:

Physical and mental health conditions that may be related to the September 11, 2001, terrorist attacks;

Diagnosing WTC-related health conditions for which there has been diagnostic uncertainty; and

Treating WTC-related health conditions for which there has been treatment uncertainty.

A major area of research interest of this announcement also includes improving the healthcare and wellbeing of at-risk survivor populations including minority groups, women exposed while pregnant or of reproductive age, the elderly, adolescents, and other minor children.

Health Equity: Project proposals should include discussion describing how research questions, data collection methods and analysis, and dissemination of results will be inclusive of the diversity in the WTC Survivor population, especially those from historically underrepresented groups including women, minorities, foreign-born individuals, and individuals of all ages, including appropriate representation of older adults and individuals exposed to the WTC disaster prior to 18 years of age.

Applicant research proposals should demonstrate:

how the design, content, format and dissemination of outreach efforts will be tailored to the needs of

Survivors from diverse backgrounds; and how historically underrepresented groups can be included in research projects, e.g., though participation on advisory boards, as researchers/staff, and though partnerships.

U01 projects involve longer term research to address critical questions about these, or other, clinical areas.

Types of clinical research areas that will be considered for potential projects include, but are not limited to:

Screening Research: Projects that evaluate current, or facilitate the development of, new/improved, methods to detect certain disorders or health conditions.

Diagnostic Research: Projects that evaluate current, or facilitate the development of, new/improved, methods to identify diseases, disorders, or conditions.

RFA-OH-22-004: World Trade Center Health Research-Related to WTC Survivors (U01 no Applications with Responders Accepted)

Treatment Research: Projects that evaluate/identify improved treatment interventions/methods (e.g., medication, psychotherapy, dietary/nutritional, care management and coordination etc.) or promote the development of new or novel treatment approaches, e.g. telemedicine.

Prevention Research: Projects that identify/evaluate new methods and interventions

(e.g., medicine(s), psychotherapy, vaccines, nutrition, or lifestyle changes) that prevent or mitigate the development or reoccurrence of various diseases/disorders.

Quality of Life Research: Projects that identify, develop, or evaluate, methods/interventions that improve comfort and the quality of life for individuals with a chronic illness or multimorbidity.

Omics Research: Projects that facilitate improvement in methods/procedures for the prediction of disorders by identifying and understanding how genes and illnesses may be related (e.g., identification of phenotypes and biomarkers). Research in this area may explore ways in which a person’s genes make him or her more or less likely to develop a disorder or respond to a medication.

Epidemiological/Clinical Research: Projects that seek to identify the patterns, causes, and control of disorders among the WTC population, including women and those exposed to 9/11 as children. These projects will also identify, implement, and improve research methods.

Health Services Research: Projects that examine how people get access to health care and care management services, how much care costs, and what happens to patients as a result of this care. Research projects in this area have the potential to identify improved methods/procedures to organize, manage, finance, and deliver health care.

Translation Research: Projects that evaluate the process whereby existing WTC Health

Program research outputs are translated into practical benefits to affected populations.

Health Equity Research: Projects that identify/develop methods to systematically determine whether there are unique vulnerabilities and health disparities among individuals exposed to the 9/11 attacks and aftermath. Vulnerable groups include but are not limited to, women, minorities, foreign-born individuals, and individuals of all ages, with appropriate representation of older adults and individuals exposed to the WTC disaster prior to 18 years of age.

Relevant diseases or conditions include, but are not limited to:

Respiratory diseases

Cancer (including detection/diagnosis of pre-malignant changes)

Cardiovascular Disease

Psychological resilience and well-being

Persistent psychiatric conditions such as posttraumatic stress, anxiety and depressive disorders

Cognitive changes

RFA-OH-22-004: World Trade Center Health Research-Related to WTC Survivors (U01 no Applications with Responders Accepted)

Aging – the impacts of aging on those impacted by 9/11 illness and injury (e.g., premature aging, optimizing adaptation for productivity)

Neurological Diseases

Aerodigestive health

Birth and Reproductive Outcomes

Multisystem or auto-immune diseases

Emerging conditions – includes diseases/conditions petitioned for consideration to the List of WTC-

Related Health Conditions, available at https://www.cdc.gov/wtc/received.html, in the section titled, Petitions Received and WTC Health Program Responses.

Objectives The overall objective of this announcement is to solicit meritorious and scientifically rigorous WTC Survivor-focused research applications that will help:

improve diagnosis and treatment activities of the WTC Health Program;

expand knowledge about health effects related to the September 11, 2001, terrorist attacks;

answer critical questions about physical and mental health conditions related to the September 11, 2001, terrorist attacks;

improve the healthcare and wellbeing of the at-risk survivor populations including minority groups, women exposed while pregnant or of reproductive age, the elderly, adolescents, and other minor children; and apply lessons learned from 9/11 to improve response to future disasters (see WTC Health Program

Research-to-Care logic model).

Researchers can review WTC Health Program funded projects and publications by visiting the WTC Health Program Research Compendium to assist with an assessment of research gaps/needs.

Another objective of this announcement is to help address the wide range of research needs related to the WTC Health Program. NIOSH will do this by considering the following types of U01 cooperative research projects for 2021 due date/FY2022 funding:

Type of Project Project Period Total Cost per Year

Long-Term Up to four years Up to $600K

Intermediate-Term Up to three years Up to $500K

Short-Term Up to two years Up to $350K

A wide range of research needs can be addressed by each type of project. NIOSH anticipates funding 2-8 long-term, intermediate-term, or short-term projects. The project period, budget and anticipated projects to fund may vary in subsequent years of this announcement.

NIOSH seeks to achieve a suitable mix of projects that help advance treatment effectiveness and the understanding of health and well-being impacts related to the

September 11, 2001, terrorist attacks among WTC survivors.

Increased knowledge of the characteristics of WTC-related illnesses and disorders, such

RFA-OH-22-004: World Trade Center Health Research-Related to WTC Survivors (U01 no Applications with Responders Accepted) as pathology, prognosis, latency, and the effects of other risk factors and comorbidities, is critical for achieving improved treatment and intervention protocols. Scientific evaluation of the translation of WTC Health Program research outputs into practical benefits enhances research integration and expedites research-to-care program objectives.

Healthy People 2030 and other National Strategic Priorities The WTC research program funded by this FOA will contribute to the CDC strategic goal, in alignment with an HHS strategic goal and objectives found in Healthy People 2030 to increase the number of communities that protect and promote health and safety and prevent illness and injury to improve the safety, quality, affordability, and accessibility of health care.

Public Health Impact A growing body of evidence suggests that significant health conditions have emerged that are associated with the disaster, particularly for those exposed during the collapse of the towers and those who participated substantially in rescue, recovery, and clean-up operations.

Research to be conducted under the Zadroga Act includes epidemiologic and other research studies on WTC-related health conditions or emerging conditions (1) among enrolled WTC responders and certified-eligible WTC survivors under treatment; and (2) in sampled populations outside the New York City disaster area in Manhattan (as far north as 14th Street) and in Brooklyn, along with (3) control populations, to identify potential for long-term adverse health effects in less exposed populations.

Scientific research may inform health care professionals and allow earlier diagnoses of

WTC conditions, which may lead to more effective treatment. However, scientifically identifying the causes of health problems or conditions is typically very difficult. While it is often not possible to determine the specific cause of an individual's illness or condition, it is critical to promote scientifically rigorous studies and reviews of potential health problems or risk factors among the affected population.

NIOSH's Research Compendium outlines the research goals and accomplishments of the

WTC Health Program, program stakeholders, and research grantees. The compendium provides the research mission as defined by the James Zadroga 9/11 Health and

Compensation Act of 2010 (Public Law 111–347, as amended by Public Laws 114–113 and 116–59). It gives a brief history of the program, an overview of the research goals, and a bibliography of all WTC Health Program-funded research project publications and links to constituent Primary Investigators and program-related websites and resources.

CDC/NIOSH solicited public comments regarding research priorities for WTC Health

Program FY2022 research projects on WTC survivors (adults and children) and similar survivor populations south of 14th street in Manhattan and in Brooklyn. The WTC Health

RFA-OH-22-004: World Trade Center Health Research-Related to WTC Survivors (U01 no Applications with Responders Accepted)

Program's research program helps answer critical questions about potential 9/11-related physical and mental health, as well as diagnosing and treating health outcomes on the List of WTC-Related Health Conditions.

The public comments (closed August 23, 2021) are shared in Docket CDC-2021-0071 at https://www.regulations.gov/document/CDC-2021-0071-0001.

Relevant Work Information about current and completed NIOSH-funded research studies pertaining to the

World Trade Center can be found at WTC Health Program Research Gateway and 9/11

Health Update (including two publications from the WTC Health Program: First Decade of

Research and A Workshop on Cognitive Aging and Impairment in the 9/11-Exposed

Population). The Registry's annual reports, prepared for enrollees and the public, include information on its key activities and accomplishments, as well as details on recent findings about the health consequences of 9/11.

The Research-to-Care Logic Model used by the WTC Health Program staff to evaluate the effectiveness of the WTC research program can be found at https://www.cdc.gov/wtc/pdfs/research_to_care.pdf.

More information can be found in the Research Compendium and public comments as described above.

Note: Interested applicants are strongly encouraged to review the Research

Compendium, information on current and completed WTC research, and the Registry's annual reports.

Target Population The target population for research funded under this FOA are individuals exposed to the

September 11, 2001, terrorist attacks, specifically community members (also referred to as survivors).

Certified-eligible WTC survivors (adults and children) include individuals who lived, worked, went to school, or attended child or adult day care in the New York City (NYC)

Disaster Area, as defined in 42 CFR 88.1, on September 11, 2001, or in the following days, weeks, or months and those otherwise meeting the eligibility criteria in 42 CFR 88.7 or 88.8 who have been identified as eligible for medical monitoring and treatment as described in 42 CFR 88.1 or 88.12(b).

In addition to certified-eligible WTC survivors, proposed research can include sampled populations outside the NYC disaster area in Manhattan as far north as 14th Street and in

Brooklyn, along with control populations, to identify potential for long-term adverse health effects in less exposed populations.

RFA-OH-22-004: World Trade Center Health Research-Related to WTC Survivors (U01 no Applications with Responders Accepted)

Collaboration/Partnerships Interdisciplinary and transdisciplinary collaborations that share expertise are essential to advance WTC Health Program efforts to 1) evaluate linkages between WTC exposures and uncommon health conditions, 2) improve diagnostic and treatment outcomes, and 3) support activities to address emerging WTC Health Program health and wellness priorities.

Ancillary Studies/Secondary Analysis of Existing Data

Applicants considering projects that depend on interaction or collaboration with the Data

Centers, or the 9/11 Health Registry associated with the WTC Health Program (“Data

Center and WTC Health Registry Contacts”, below) must coordinate in advance with the respective Directors or Administrators of the Data Centers to ensure access to data and/or availability of adequate numbers of potential participants are feasible to conduct the proposed research. Documentation of the study recruitment plan and agreement on this coordination must be included in the application, along with any budgetary needs for the coordination activities, by providing both a letter from the investigator to the Data

Center/Health Registry/WTC Health Program and a response letter from the Data

Center/Health Registry/WTC Health Program to the investigator.

Data Center and WTC Health Registry Contacts

Fire Department of New York

Medical Director – Dr. David Prezant, 718-999-2696, david.prezant@fdny.nyc.gov

Administrative Director – Ms. Jessica Weakley, 718-999-0412, Jessica.Weakley@fdny.nyc.gov

Mount Sinai School of Medicine

Director – Dr. Andrew C. Todd, 212-824-7053, andrew.todd@mssm.edu

Data Requests – Mr. Christopher R. Dasaro, 212-241-1568, christopher.dasaro@mssm.edu

NYC Health and Hospitals Corporation

Medical Director – Dr. Joan Reibman, 212-263-6479, Joan.Reibman@nychhc.org

Executive Director – Ms. Angeles Pai, 212-788-3466, paia@nychhc.org

Data Center Director—Ms. Michelle Hyde, 212-788-0949, Michelle.Hyde@nychhc.org

WTC Health Registry

Public Affairs Manager – Jacquelynn Osoro, 718-786-4411, josoro@health.nyc.gov

Evaluation/Performance Measurement

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Evaluations provide information for management and improve program effectiveness. The

CDC document Framework for Program Evaluation can be helpful.

Effective program evaluation is a systematic way to improve and account for public health actions by involving procedures that are useful, feasible, ethical, and accurate.

Understanding and applying the elements of this framework for research projects may enhance planning effective public health strategies, improving existing programs including evidence-based activities, and demonstrating beneficial results and impact of federal funding.

Translation Plan When relevant to the goals of the research project, applicants should describe briefly how the findings may be used to promote, enhance, or advance translation of the research into practice or may be used to inform public health policy. See WTC Health Program

Research-to-Care logic model.

Data/Resource Sharing Plan NIOSH considers the sharing of unique data and other research resources developed through the WTC Health Program an important means to enhance the value, and further the advancement of, current and future research.

Investigators responding to this funding opportunity should include a plan on sharing research resources and data or explain why such sharing is not possible. The precise content of the plan will vary depending on the data being collected and how the investigator is planning to share the data.

Factors to consider include: the expected schedule for data sharing, the format of the final dataset, supporting documentation, and whether analytic tools will be provided. Other considerations include whether a data sharing agreement will be required, whether any conditions will be placed on their use, and the mode of data sharing.

Information on data/resource sharing can be found on page II-74 (Sharing Research

Tools) of the current HHS Grants Policy.

HHS/CDC policy requires that grant award recipients make unique research resources and data readily available for research purposes to qualified individuals within the scientific community after publication.

Individuals are required to comply with the instructions for the Resource Sharing Plans

(Data Sharing Plan; Sharing Model Organisms; and Genome Wide Association Studies

[GWAS]), as provided in the SF424 (R&R) Application Guide.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

RFA-OH-22-004: World Trade Center Health Research-Related to WTC Survivors (U01 no Applications with Responders Accepted)

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial

Federal scientific or programmatic involvement. Substantial involvement means that, after award, CDC scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed

New

Renewal

Resubmission

Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s)

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

An estimate of $12M in total cost (direct and indirect) is available over a 4-year period

FY2022-FY2025. NIOSH anticipates funding 2-8 long-term, intermediate-term, or short-term projects.

Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications. Each year the number of new, renewal and resubmission awards and the total amount awarded will vary, depending on the number of awards that have been completed; the availability of funds; the number and quality of applications; and the duration and cost of the projects proposed. Because the nature and scope of the proposed research will vary from application to application, the size and duration of each award may also vary.

Award Budget

Applicants submitting applications for 2021 due date/FY2022 funding may apply for one of the following: (1) a project period of up to 4 years and a total budget up to $600K per year in direct and indirect costs (total costs); (2) a project period of up to 3 years and a total budget up to $500K per year in direct and indirect costs (total costs); or (3) a project period of up to 2 years and a total budget up to $350K per year in direct and indirect costs

RFA-OH-22-004: World Trade Center Health Research-Related to WTC Survivors (U01 no Applications with Responders Accepted)

HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for CDC/NIOSH support as Public or Private Institutions of Higher Education:

o Hispanic-serving Institutions o Historically Black Colleges and Universities (HBCUs) o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutions o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)

Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

Small Businesses

For-Profit Organizations (Other than Small Businesses)

Governments

State Governments

County Governments

City or Township Governments

Special District Governments

(total costs). The project period and budget vary in subsequent years.

Award Project Period

Allowable project period options are up to 4 years for a long-term project, up to 3 years for an intermediate-term project, or up to 2 years for a short-term project for 2021 due date/FY2022 funding. The allowable project periods vary in subsequent years.

Throughout the project period, CDC's commitment to continuation of awards will be conditional on the availability of funds, evidence of satisfactory progress by the recipient

(as documented in required reports), and the determination that continued funding is in the best interest of the Federal government.

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Indian/Native American Tribal Governments (Federally Recognized)

Indian/Native American Tribal Governments (Other than Federally Recognized)

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Other

Independent School Districts

Public Housing Authorities/Indian Housing Authorities

Native American Tribal Organizations (other than Federally recognized tribal governments)

Faith-based or Community-based Organizations

Regional Organizations

Bona Fide Agents: a Bona Fide Agent is an agency/organization identified by the state as eligible to apply under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other

Attachment Forms" when submitting via www.grants.gov.

Federally Funded Research and Development Centers (FFRDCs): FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency's existing in-house or contractor resources. FFRDC's enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. Click here for more information on FFRDCs.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

For this announcement, applicants may include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System

(DUNS) number in order to begin each of the following registrations. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH

Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

RFA-OH-22-004: World Trade Center Health Research-Related to WTC Survivors (U01 no Applications with Responders Accepted)

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA

Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity

(CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

o NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an

NCAGE code (in lieu of a CAGE code) in order to register in SAM.

eRA Commons - Applicants must have an active DUNS number to register in eRA Commons.

Organizations can register with the eRA Commons as they are working through their SAM or

Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program

Director/Principal Investigator (PD/PI) account in order to submit an application.

Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration. All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The one-time registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. All Senior/Key Personnel, including PD(s)/PI(s), must work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA

Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for CDC/NIOSH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program

Director/Principal Investigator Policy and submission details in the Senior/Key Person

Profile (Expanded) Component of the SF424 (R&R) Application Guide.

When multiple PDs/PIs are proposed, NIOSH requires one PD/PI to be designated as the

"Contact" PI, who will be responsible for all communications between the PDs/PIs and the

NIOSH, for assembling the application materials outlined below, and for coordinating progress reports. The Contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs.

RFA-OH-22-004: World Trade Center Health Research-Related to WTC Survivors (U01 no Applications with Responders Accepted)

NOTE: The CDC does not make awards to individuals directly.

2. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.

3. Additional Information on Eligibility Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct. As defined in the HHS Grants Policy Statement, applications received in response to the same Notice of Funding Opportunity

Announcement generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit.

CDC/NIOSH will not accept duplicate or highly overlapping applications under review at the same time. This means that the CDC/NIOSH will not accept:

A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

In addition, NIOSH will not accept any application in response to this FOA that is essentially the same as one previously reviewed, or as one currently pending initial peer review unless the applicant withdraws the pending application. Resubmission applications may be submitted, according to the Policy on Resubmission Applications from the SF424

(R&R) Application Guide but must include an Introduction addressing the previous peer review critique (Summary Statement).

Responsiveness

See Section I. Target Population for descriptions of allowed WTC subpopulation. No applications with responders are accepted for this FOA.

Applications that exceed the period of performance limit or the total cost per year

(including consortium F&A costs) of the proposed project type (long-, intermediate- or short-term) will be considered nonresponsive and will not be reviewed. In these cases, CDC/NIOSH will notify the applicant and request that the application be withdrawn.

The Research Strategy component of the Research Plan is limited to 12 pages for a long-term (up to 4 years) project. Proposals for intermediate-term (up to 3 years) or short-term

(up to 2 years) projects shall limit their Research Strategy to 8 pages. These page limits are the totals for all text, tables, graphs, figures, diagrams, and charts in this component.

Upon receipt, applications will be evaluated for completeness by NIH/CSR and

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CDC/NIOSH. CDC/NIOSH will screen all applications for responsiveness. Incomplete or non-responsive applications will not be reviewed. Applicants will be requested to withdraw non-responsive applications.

Note to Applicants

You must list the Study Design of your proposed study with a brief description.

You must specify the WTC Subpopulation under study (WTC survivors; see Section I. Target

Population for descriptions). No applications with responders are accepted for this FOA. If you propose to study FDNY responders, general responders or a combination of WTC responders and survivors, you must submit your applications to the funding announcement PAR-20-280 for funding consideration by the

NIOSH WTC Health Program.

You must also include the primary diseases or conditions listed in Section I of this announcement (e.g., respiratory disease, adult mental health, cancer, children’s research or emerging conditions) that you propose to study, with a brief description of the diseases or conditions.

The Study Design, WTC Subpopulation under study and Primary Diseases/Conditions should be included as one attachment titled "Study Information" in the "12. Other Attachments" section of the "R&R

Other Project Information" section of the application. Please note there are other requirements specific to this announcement that must be included in your application: Project Dissemination Plan, Project

Evaluation Plan, Resource Sharing Plan and Data Management Plan (see Section IV, 2. Content and

Form of Application Submission for information and place to upload the contents), as well as CDC Risk

Questionnaire and if applicable, Duplication of Efforts (see Section IV, 7. Other Submission Requirements and Information for instructions).

The NIOSH Secondary Review Committee (SRC) may categorize and prioritize projects by primary diseases or conditions listed in Section I of this announcement based on program needs.

Diseases/Conditions Requiring Further Program Consideration

Applicants may propose to study Other Diseases/Conditions requiring further program consideration. A list of these diseases/conditions is found at https://www.cdc.gov/wtc/received.html, in the section titled, Petitions Received and WTC

Health Program Responses.

WTC Health Program Reference Documents

The WTC Health Program Research Compendium

NIOSH's Research Compendium outlines the research goals and accomplishments of the

WTC Health Program, program stakeholders, and research grantees. The compendium provides the research mission as defined by the James Zadroga 9/11 Health and

Compensation Act of 2010. It gives a brief history of the program, an overview of the research goals, and a bibliography of all WTC Health Program-funded research project publications and links to constituent Primary Investigators and program-related websites and resources.

Public Input on the Scope of FY2022 WTC Health Program Research Activities on WTC

Survivors

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CDC/NIOSH solicited public comments regarding research priorities for WTC Health

Program FY2022 research projects on WTC survivors (adults and children) and similar survivor populations south of 14th street in Manhattan and in Brooklyn. The WTC Health

Program's research program helps answer critical questions about potential 9/11-related physical and mental health, as well as diagnosing and treating health outcomes on the List of WTC-Related Health Conditions.

The public comments (closed August 23, 2021) are shared in Docket CDC-2021-0071 at https://www.regulations.gov/document/CDC-2021-0071-0001.

Note: Interested applicants are strongly encouraged to review the WTC Health Program

Research Compendium, information on current and completed WTC research, and the

Registry's annual reports.

Section IV. Application and Submission Information

1. Requesting an Application Package The SF424 R&R application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution.

Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA.

Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or

Grants.gov Workspace are options. ASSIST is a commonly used platform because, unlike other platforms, it provides a validation of all requirements prior to submission and prevents errors.

To use ASSIST, applicants must visit https://public.era.nih.gov where you can login using your eRA Commons credentials, and enter the Notice of Funding Opportunity Number to initiate the application, and begin the application preparation process.

If you experience problems accessing or using ASSIST, you can refer to the ASSIST online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service Desk via:

• E-mail: http://grants.nih.gov/support/index.html.

• Phone: 301-402-7469 or (toll-free) 1-866-504-9552.

The NIH eRA Service desk is available Monday-Friday, 7 a.m. to 8 p.m. Eastern Time, excluding federal holidays.

2. Content and Form of Application Submission It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R)

Application Guide, including Supplemental Grant Application Instructions, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the

RFA-OH-22-004: World Trade Center Health Research-Related to WTC Survivors (U01 no Applications with Responders Accepted) requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate

“optional” components.

When using ASSIST, all mandatory forms will appear as separate tabs at the top of the

Application Information screen; applicants may add optional forms available for the FOA by selecting the Add Optional Form button in the left navigation panel.

In conjunction with the SF424 (R&R) components, CDC grants applicants should also complete and submit additional components titled “PHS398.” Note the PHS398 should include assurances and certifications, additional data required by the agency for a complete application. While these are not identical to the PHS398 application form pages, the PHS398 reference is used to distinguish these additional data requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include both SF424 (R&R) and PHS398 components. These forms can be downloaded from https://grants.nih.gov/grants/forms.htm.

For information on Application Submission and Receipt, visit Frequently Asked Questions

– Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed activity

Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)

Names of other key personnel

Participating institution(s)

Number and title of this funding opportunity

The letter of intent should be sent to:

Michael Goldcamp, PhD

Scientific Review Official

National Institute for Occupational Safety and Health (NIOSH)

Centers for Disease Control and Prevention (CDC)

Telephone: 304-285-5951

Email: MGoldcamp@cdc.gov

Page Limitations

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All page limitations described in the SF424 Application Guide and the Table of Page

Limits must be followed. with the following exceptions or additional requirements:

the Research Strategy component of the Research Plan is limited to 12 pages for…